Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound System— 510(k) K182427
Substantially EquivalentCanon Medical Systems Corporation
FDA 510(k) clearance K182427 for Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound System, Substantially Equivalent on 2018-11-02. Applicant: Canon Medical Systems Corporation. Device class: 2.
Clearance details
- Applicant
- Canon Medical Systems Corporation
- Product code
- Product code IYN
- Device class
- Class 2
- Regulation
- 21 CFR 892.1550
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Otawara-Shi, JP
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Adverse events under product code IYN
product code IYN- Death
- 25
- Injury
- 163
- Malfunction
- 1,538
- Other
- 4
- Total
- 1,730
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.